55 SV, MULTIFOCAL AND TORIC (OCUFILCON C) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
FDA 510(k) clearance K051184 · decided 2005-07-01
Clearance details
- K-number
- K051184
- Device name
- 55 SV, MULTIFOCAL AND TORIC (OCUFILCON C) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
- Applicant
- United Contact Lens, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-05-09
- Decision date
- 2005-07-01
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Felton, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS (P870079/S003) | United Contact Lens, Inc. | 1990-03-29 |
| TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS (P870079/S005) | United Contact Lens, Inc. | 1990-01-22 |
| TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS (P870079/S002) | United Contact Lens, Inc. | 1989-06-02 |
| TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS (P870079/S001) | United Contact Lens, Inc. | 1989-05-26 |